U.S. patent application number 12/445919 was filed with the patent office on 2013-07-18 for vessel support device and method of vessel harvesting.
This patent application is currently assigned to SCOTTSDALE MEDICAL DEVICES, INC.. The applicant listed for this patent is Matthew D. Bonner, Roderick E. Briscoe, Steven C. Christian, Cynthia T. Clague, Thomas P. Daigle, Philip J. Haarstad, Michael J. Hobday, Scott E. Jahns, Katherine S. Jolly, James R. Keogh, Ana R. Menk, Eric A. Meyer, Christopher P. Olig, Robert H. Reetz, Jeffrey D. Sandstrom, Raymond W. Usher. Invention is credited to Matthew D. Bonner, Roderick E. Briscoe, Steven C. Christian, Cynthia T. Clague, Thomas P. Daigle, Philip J. Haarstad, Michael J. Hobday, Scott E. Jahns, Katherine S. Jolly, James R. Keogh, Ana R. Menk, Eric A. Meyer, Christopher P. Olig, Robert H. Reetz, Jeffrey D. Sandstrom, Raymond W. Usher.
Application Number | 20130184727 12/445919 |
Document ID | / |
Family ID | 39314635 |
Filed Date | 2013-07-18 |
United States Patent
Application |
20130184727 |
Kind Code |
A1 |
Clague; Cynthia T. ; et
al. |
July 18, 2013 |
VESSEL SUPPORT DEVICE AND METHOD OF VESSEL HARVESTING
Abstract
Embodiments of the invention provide a vessel support system and
a method of vessel harvesting. The system can include a cutting
device, a catheter adapted to be inserted into a section of the
vessel in order to support the vessel as the cutting device is
advanced over the vessel, and a cannula adapted to be coupled to
the vessel and adapted to receive the catheter as the catheter is
inserted into the section of the vessel. The method can include
orienting a cutting device coaxially with the cannula and the
catheter and advancing the cutting device over the cannula, the
catheter, and the section of the vessel in order to core out the
section of the vessel and a portion of the surrounding tissue.
Inventors: |
Clague; Cynthia T.;
(Minnetonka, MN) ; Hobday; Michael J.; (Lino
Lakes, MN) ; Usher; Raymond W.; (Coon Rapids, MN)
; Briscoe; Roderick E.; (Rogers, MN) ; Jolly;
Katherine S.; (Eden Prairie, MN) ; Menk; Ana R.;
(Minneapolis, MN) ; Olig; Christopher P.; (Eden
Prairie, MN) ; Meyer; Eric A.; (Andover, MN) ;
Christian; Steven C.; (New Brighton, MN) ; Daigle;
Thomas P.; (Hanover, MN) ; Reetz; Robert H.;
(Rockford, MN) ; Sandstrom; Jeffrey D.; (Forest
Lake, MN) ; Keogh; James R.; (Maplewood, MN) ;
Bonner; Matthew D.; (Plymouth, MN) ; Jahns; Scott
E.; (Hudson, WI) ; Haarstad; Philip J.;
(Chanhassen, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Clague; Cynthia T.
Hobday; Michael J.
Usher; Raymond W.
Briscoe; Roderick E.
Jolly; Katherine S.
Menk; Ana R.
Olig; Christopher P.
Meyer; Eric A.
Christian; Steven C.
Daigle; Thomas P.
Reetz; Robert H.
Sandstrom; Jeffrey D.
Keogh; James R.
Bonner; Matthew D.
Jahns; Scott E.
Haarstad; Philip J. |
Minnetonka
Lino Lakes
Coon Rapids
Rogers
Eden Prairie
Minneapolis
Eden Prairie
Andover
New Brighton
Hanover
Rockford
Forest Lake
Maplewood
Plymouth
Hudson
Chanhassen |
MN
MN
MN
MN
MN
MN
MN
MN
MN
MN
MN
MN
MN
MN
WI
MN |
US
US
US
US
US
US
US
US
US
US
US
US
US
US
US
US |
|
|
Assignee: |
SCOTTSDALE MEDICAL DEVICES,
INC.
Scottsdale
AZ
|
Family ID: |
39314635 |
Appl. No.: |
12/445919 |
Filed: |
October 16, 2007 |
PCT Filed: |
October 16, 2007 |
PCT NO: |
PCT/US07/22036 |
371 Date: |
February 28, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60852020 |
Oct 16, 2006 |
|
|
|
Current U.S.
Class: |
606/159 |
Current CPC
Class: |
A61B 17/00008 20130101;
A61B 17/32 20130101; A61B 17/32053 20130101; A61B 17/3205 20130101;
A61B 2017/320064 20130101 |
Class at
Publication: |
606/159 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. A system for harvesting a section of a vessel from surrounding
tissue, the system comprising: a cutting device adapted to surround
the vessel along the section of the vessel and adapted to be moved
along the section of the vessel in order to cut the surrounding
tissue; a catheter adapted to be inserted into the section of the
vessel in order to support the vessel as the cutting device is
advanced over the vessel; and a cannula adapted to be coupled to
the vessel and adapted to receive the catheter as the catheter is
inserted into the section of the vessel.
2. The system of claim 1 wherein the catheter is a balloon
catheter.
3. The system of claim 1 wherein the catheter is coupled to a
guidewire that is inserted into the vessel before the catheter.
4. The system of claim 1 and further comprising a tensioning device
coupled to the cannula to hold an end of the vessel in tension
while the cutting device is advanced along the vessel.
5. The system of claim 1 wherein the catheter includes at least one
lumen adapted to be coupled to at least one fluid source.
6. The system of claim 1 and further comprising a handle adapted to
be removeably coupled to a proximal end of the catheter.
7. The system of claim 6 and further comprising a rod adapted to be
positioned within the catheter and adapted to be attached to the
handle.
8. A method of harvesting a section of a vessel from surrounding
tissue, the method comprising: making a first incision at a
proximal end of the section of the vessel; making a second incision
at a distal end of the section of the vessel; inserting a cannula
into the proximal end of the vessel; securing the proximal end of
the vessel to the cannula; inserting a catheter through the cannula
and into the section of the vessel; orienting a cutting device
coaxially with the cannula and the catheter; and advancing the
cutting device over the cannula, the catheter, and the section of
the vessel in order to core out the section of the vessel and a
portion of the surrounding tissue.
9. The method of claim 8 and further comprising inserting a
guidewire through the vessel before making the second incision.
10. The method of claim 8 and further comprising inserting a
guidewire through the vessel so that a first end of the guidewire
extends beyond the proximal end of the vessel and a second end of
the guidewire extends beyond the distal end of the vessel.
11. The method of claim 8 wherein the catheter is a balloon
catheter and further comprising inflating the balloon catheter to
support the vessel as the cutting device is advanced over the
vessel.
12. The method of claim 8 and further comprising attaching a
tensioning device to the cannula before advancing the cutting
device over the cannula.
13. An intravascular balloon catheter for use in supporting a
section of a vessel being harvested from surrounding tissue with a
cutting device, the catheter comprising: a balloon including a
proximal end and a distal end, the proximal end being plugged, the
distal end including a routing neck, the balloon adapted to be
inflated in the vessel in order to support the vessel as the
cutting device is advanced along the vessel; and a stylet coupled
to the routing neck of the balloon, the stylet including a flexible
tip and a coiled wire adapted to navigate through the vessel in
order to position the balloon in the section of the vessel.
14. The catheter of claim 13 and further comprising a flexible
sheath covering the balloon.
15. The catheter of claim 14 wherein the flexible sheath expands
with the balloon when the balloon is inflated.
16. The catheter of claim 14 wherein the flexible sheath helps
deflate the balloon into a low profile configuration so that the
balloon can be removed from the vessel.
17. The catheter of claim 13 wherein the balloon is inflated with
saline solution.
18. The catheter of claim 13 wherein the flexible tip minimizes
damage to walls of the vessel.
19. The catheter of claim 13 wherein a proximal end of the stylet
is positioned within the routing neck of the balloon.
20. A cannula for use in harvesting a section of a vessel, the
cannula adapted to be coupled to a tensioning device, the cannula
comprising: a distal tip adapted to be inserted into and secured to
a proximal end of the section of the vessel; a valve adapted to
prevent fluid flow out of the proximal end of the section of the
vessel, the valve positioned in a proximal end of the cannula; a
tension-coupling member in the proximal end of the cannula, the
tension-coupling member including at least one groove adapted to
receive at least one raised bump of a tensioning device member
adapted to be coupled to the tensioning device.
21. The cannula of claim 20 wherein the valve is one of a bileaflet
valve and a duckbill valve.
22. The cannula of claim 20 wherein the distal tip includes an
angled portion.
23. The cannula of claim 20 wherein a first diameter of the distal
tip is smaller than a second diameter of the proximal end of the
cannula.
24. The cannula of claim 20 wherein the valve is positioned between
the distal tip and the tension-coupling member.
25. The cannula of claim 20 wherein the distal tip includes a ridge
around which sutures can be wrapped to secure the cannula to the
proximal end of the section of the vessel.
Description
RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. .sctn.119
to U.S. Provisional Patent Application Ser. No. 60/852,020, filed
on Oct. 16, 2006, the entire contents of which is hereby
incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates generally to biomedical systems and
methods. More specifically, the invention relates to systems and
methods for harvesting a vessel section.
BACKGROUND
[0003] Heart disease, specifically coronary artery disease, is a
major cause of death, disability, and healthcare expense in the
United States and other industrialized countries. A common form of
heart disease is atherosclerosis, in which the vessels leading to
the heart are damaged or obstructed by plaques containing
cholesterol, lipoid material, lipophages, and other materials. When
severely damaged or obstructed, one or more of the vessels can be
bypassed during a coronary artery bypass graft (CABG) procedure.
CABG surgery is performed about 350,000 times annually in the
United States, making it one of the most commonly performed major
operations.
[0004] To prevent rejection, the graft material is preferably a
blood vessel harvested from elsewhere within a patient's body. The
most frequently used bypass vessel is the saphenous vein from the
leg. Because the venous system of the leg is redundant, other veins
that remain within the patient's leg are able to provide return
blood flow following removal of the saphenous vein.
[0005] Various methods have been used to harvest the saphenous
vein. Until recently, the typical procedure involved making a
single long incision that overlies the entire length of the vein,
extending from a patient's groin to at least the knee and often to
the ankle. This method results in substantial postoperative pain,
with patients frequently complaining more of discomfort at the site
of the leg vein harvesting than of pain from their CABG surgery
wound. In addition, such an extensive incision site is subject to
infection and delayed healing, especially in patients with poor
circulation, which not infrequently accompanies coronary artery
disease. The disfiguring scar from such a large incision is also of
concern to some patients.
[0006] Less invasive procedures are preferred, and surgical devices
and techniques now exist that allow the saphenous vein to be
harvested through one or more small, transverse incisions along the
length of the vein, generally using an endoscope. Endoscopic
procedures yield reduced wound complications and superior cosmetic
results compared with traditional methods of vein harvesting.
However, this procedure requires considerable manipulation of the
vein, has a high conversion rate when visualization is obscured by
bleeding or the procedure is taking too long and often requires
stitches to repair the vein following harvest. Further, it is
generally tedious, time consuming, and relatively complex,
requiring extensive accessory equipment and a substantial learning
curve for the surgeon.
SUMMARY
[0007] Some embodiments of the invention provide a system for
harvesting a section of a vessel from surrounding tissue. The
system can include a cutting device adapted to surround the vessel
along the section of the vessel and adapted to be moved along the
section of the vessel in order to cut the tissue around the vessel.
The system can also include a catheter adapted to be inserted into
the section of the vessel in order to support the vessel as the
cutting device is advanced over the vessel. The system can further
include a cannula adapted to be coupled to the vessel and adapted
to receive the catheter as the catheter is inserted into the
section of the vessel.
[0008] According to a method of the invention, a section of a
vessel can be harvested from surrounding tissue by making a first
incision at a proximal end of the section of the vessel, and making
a second incision at a distal end of the section of the vessel. The
method can include inserting a cannula into the proximal end of the
vessel, and securing the proximal end of the vessel to the cannula.
The method can also include inserting a catheter through the
cannula and into the section of the vessel, and orienting a cutting
device coaxially with the cannula and the catheter. The method can
further include advancing the cutting device over the cannula, the
catheter, and the section of the vessel in order to core out the
section of the vessel and a portion of the surrounding tissue.
[0009] One embodiment of the invention provides an intravascular
balloon catheter for use in supporting a section of a vessel being
harvested from surrounding tissue with a cutting device. The
catheter includes a balloon with a proximal end and a distal end,
the proximal end being plugged and the distal end including a
routing neck. The balloon is adapted to be inflated in the vessel
in order to support the vessel as the cutting device is advanced
along the vessel. The catheter also includes a stylet coupled to
the routing neck of the balloon. The stylet includes a flexible tip
and a coiled wire adapted to navigate through the vessel in order
to position the balloon in the section of the vessel.
[0010] Another embodiment of the invention provides a cannula for
use in harvesting a section of a vessel. The cannula includes a
distal tip adapted to be inserted into and secured to a proximal
end of the section of the vessel. The cannula also includes a valve
adapted to prevent fluid flow out of the proximal end of the
section of the vessel, with the valve positioned in a proximal end
of the cannula. The cannula further includes a tension-coupling
member adapted to be coupled to a tensioning device, with the
tension-coupling member being coupled to the proximal end of the
cannula. The tension-coupling member includes at least one groove
adapted to receive at least one raised bump of a tensioning device
member adapted to be coupled to a tensioning device.
DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is an illustration of a system for harvesting a
vessel section in accordance with embodiments of the invention;
[0012] FIGS. 2A-2B are flow diagrams of vessel harvesting methods
in accordance with embodiments of the invention;
[0013] FIGS. 3A-3D are illustrations of a roll-out intravascular
sheath for harvesting a vessel section in some embodiments of the
invention;
[0014] FIGS. 4A-4F are illustrations of a one piece intravascular
catheter balloon and stylet for harvesting a vessel section in some
embodiments of the invention;
[0015] FIGS. 5A-5E are illustrations of a cannula and tensioning
device member for use in harvesting a vessel section in some
embodiments of the invention;
[0016] FIG. 6 is an illustration of an insertion device for a flow
delivered tethered balloon for use in harvesting a vessel section
in some embodiments of the invention;
[0017] FIGS. 7A-7C are illustrations of vessel support devices for
use in harvesting a vessel section in some embodiments of the
invention;
[0018] FIG. 8 is an illustration of a vein illumination device for
use in harvesting vessel sections in some embodiments of the
invention;
[0019] FIG. 9 is an illustration of a catheter guide for use in
harvesting vessel sections in some embodiments of the
invention;
[0020] FIG. 10 is an illustration of a hemostatic control method
for use in harvesting vessel sections in some embodiments of the
invention; and
[0021] FIG. 11 is an illustration of a vessel location and
hemostasis method for use in harvesting vessel sections in some
embodiments of the invention.
DETAILED DESCRIPTION
[0022] Before any embodiments of the invention are explained in
detail, it is to be understood that the invention is not limited in
its application to the details of construction and the arrangement
of components set forth in the following description or illustrated
in the following drawings. The invention is capable of other
embodiments and of being practiced or of being carried out in
various ways. Also, it is to be understood that the phraseology and
terminology used herein is for the purpose of description and
should not be regarded as limiting. The use of "including,"
"comprising," or "having" and variations thereof herein is meant to
encompass the items listed thereafter and equivalents thereof as
well as additional items. Unless specified or limited otherwise,
the terms "mounted," "connected," "supported," and "coupled" and
variations thereof are used broadly and encompass both direct and
indirect mountings, connections, supports, and couplings. Further,
"connected" and "coupled" are not restricted to physical or
mechanical connections or couplings.
[0023] The following discussion is presented to enable a person
skilled in the art to make and use embodiments of the invention.
Various modifications to the illustrated embodiments will be
readily apparent to those skilled in the art, and the generic
principles herein can be applied to other embodiments and
applications without departing from embodiments of the invention.
Thus, embodiments of the invention are not intended to be limited
to embodiments shown, but are to be accorded the widest scope
consistent with the principles and features disclosed herein. The
following detailed description is to be read with reference to the
figures, in which like elements in different figures have like
reference numerals. The figures, which are not necessarily to
scale, depict selected embodiments and are not intended to limit
the scope of embodiments of the invention. Skilled artisans will
recognize the examples provided herein have many useful
alternatives and fall within the scope of embodiments of the
invention.
[0024] As used in this specification and in the appended claims,
the terms "distal" and "proximal" are with reference to the
operator when the device is in use.
[0025] FIG. 1 illustrates a vessel harvesting system 300 according
to some embodiments of the invention. The system 300 can include a
catheter 310, a rod 320, a handle 330, and a tubular cutting device
340. The system 300 can also include a guidewire and can be used in
conjunction with a hemostatic control method for treating severed
branch vessels.
[0026] The catheter 310 and the guidewire can be constructed of a
suitable biocompatible materials or combinations thereof, for
example, a polymer, stainless steel, nitinol, composites, etc. The
lengths of the catheter 310 and guidewire can be roughly determined
by the length of the vessel section to be harvested. The rod 320,
the catheter 310, and/or the guidewire can be coated with a
lubricious, slippery material. For example, the catheter 310 can be
coated with a slippery material to decrease friction between the
catheter 310 and the vessel to ease passage of the catheter 310
into the vessel and decrease the possibility of damaging the vessel
interior. The coating can be, for example, a hydrogel coating,
polyacrylamide, polyethylene oxide, Teflon, parylene, etc. The
coating can also contain one or more biological agents, such as an
anticoagulant or an antithrombogenic agent to reduce clotting
inside the vessel during the harvest procedure. In one embodiment,
the anticoagulant can be heparin.
[0027] In some embodiments, the coating can contain one or more
vasoactive agents or drugs, such as vasodilative agents or drugs
and/or vasoconstrictive agents or drugs. Examples of a vasodilative
drugs include, but are not limited to, a vasodilator, an organic
nitrate, isosorbide mononitrate, a mononitrate, isosorbide
dinitrate, a dinitrate, nitroglycerin, a trinitrate, minoxidil,
sodium nitroprusside, hydralazine hydrochloride, nitric oxide,
nicardipine hydrochloride, fenoldopam mesylate, diazoxide,
enalaprilat, epoprostenol sodium, a prostaglandin, milrinone
lactate, a bipyridine and a dopamine D.sub.1-like receptor agonist,
stimulant or activator. Examples of vasoconstrictive drugs include,
but are not limited to, a vasoconstrictor, a sympathomimetic,
methoxamine hydrochloride, epinephrine, midodrine hydrochloride,
desglymidodrine, and an alpha-receptor agonist, stimulant or
activator. In one embodiment, vasoactive agents or drugs can be
administered via one or more bolus injections and/or infusions or
combinations thereof. The injections and/or infusions can be
continuous or intermittent. The injections and/or infusions can be
made directly into the vessel section to be harvested.
[0028] In one embodiment, the catheter 310 is strong enough to
receive the rod 320 within a lumen of the catheter 310 and has an
outer diameter smaller than the narrowest inner diameter of the
vessel to be harvested. The catheter 310 can include one or more
lumens. In one embodiment, the catheter 310 can include one or more
fluid openings fluidly connected to one or more lumens for
delivering or introducing fluids into one or more portions of the
vessel to be harvested. The one or more lumens can be fluidly
coupled to one or more fluid sources. For example, one or more
fluids can be introduced from one or more fluid sources into the
vessel to be harvested through the one or more fluid openings prior
to removing the catheter 310 from the harvested the vessel. One or
more fluids also can be introduced into the vessel through the one
or more fluid openings while introducing the catheter 310 into the
vessel to be harvested. In one embodiment, suction or a negative
pressure can be introduced into the vessel through the one or more
fluid openings. For example, suction can be provided from a suction
source coupled to the one or more lumens which, in-turn, are
coupled to the one or more fluid openings to draw and hold the
vessel to be harvested to the catheter 310 while advancing the
cutting device 340 over the vessel and along the catheter 310.
[0029] In one embodiment, the catheter 310 can include one or more
balloons, distensible members and/or inflatable members fluidly
coupled to one or more lumens. Following placement of the catheter
310 into the vessel section to be harvested, one or more inflatable
members can be inflated via a gas or liquid, thereby securing the
vessel to the catheter 310. The gas or liquid can be, for example,
air, carbon dioxide, or saline. The one or more inflatable members
can be inflated while advancing the cutting device 340 over the
vessel and along the catheter 310.
[0030] In some embodiments, a balloon catheter 310 that provides
vessel support can also provide a centering function. The balloon
catheter 310 can include one or more inflatable structures or
elements that can be alternately inflated and deflated. The
inflatable structure or structures can expand into the lumen of an
inner or outer tubular member of the cutting device 340. The
expansion can force the vessel and the tissue surrounding it into
the center of the member to thereby center the cutting element 340
on the vessel. The structure or structures can be inflated to
center the vessel and then the cutting element 340 used to cut the
tissue adjoining the vessel. The structure or structures can then
be deflated to advance the cutting device 340 along the vessel.
After advancing the cutting device 340, the structure or structures
can again be inflated and the cutting element 340 can be used to
cut the tissue around the vessel. The process of incrementally
inflating, cutting, deflating, and advancing can be repeated until
the entire section has been excised. In one embodiment, the
structure or structures can be inflated the entire time the cutting
element 340 is advanced along the vessel.
[0031] The rod 320 can be an appropriate rigid biocompatible
material, for example stainless steel or a rigid polymer. In one
embodiment, the rod 320 is long enough to extend beyond at least
the proximal end of the vessel section to be harvested and to be
attached to the handle 330.
[0032] The handle 330 can be constructed of stainless steel;
however, other appropriate materials such as other metals and/or
suitable polymers can be used. A proximal end of the catheter 310
can be removably attached to the handle 330. FIG. 1 illustrates a
taper fitting 312 on the proximal end of the catheter 310 that
slips over a complementary taper fitting 332 on the distal end of
the handle 330 and secures the catheter 310 to the handle 330.
Other fittings, for example, a screw fitting, can also be used. In
an alternative embodiment, a proximal portion of the catheter 310
can instead be attached to a proximal portion of the rod 320 after
the rod 320 has been inserted into the catheter 310. The catheter
310 can also attach to the proximal or mid-portion of the handle
330 and the vessel can attach to the distal end of the handle
330.
[0033] The handle 330 can include a cavity 334 within which a
proximal portion of the rod 320 is received. The cavity 334 can be
contained within the handle 330, as shown in FIG. 1. Alternatively,
the cavity 334 can extend through the handle 330, allowing the
length of the portion of the rod 320 that extends from the handle
330 to be variable. A setscrew or other appropriate device can be
used to secure the rod 320 within the cavity 334.
[0034] Alternatively, a vessel cannula 851 (as shown and described
with respect to FIGS. 5A-5D) can be secured to the vessel. The
catheter 310 can be passed through the cannula 851 into the vessel
until a small portion remains within the cannula 851. The catheter
310 can then be inflated or expanded to support the vessel. The
expansion in the cannula 851 can help to hold the catheter 310 in
place. A tensioning device can then be attached to the cannula 851
to hold the end of the vessel in place while the cutting device 340
is advanced along the outside of the vessel.
[0035] As shown in FIG. 1, the cutting device 340 can include an
outer tubular member 110 and an inner tubular member 120. The outer
tubular member 110 can include a cutting element 130 positioned
adjacent to its distal end. In some embodiments, the tubular
members 110, 120 can be advanced independently of each other. The
cutting device 340 can include a centering member for centering the
vessel within the cutting device 340. In an alternative embodiment,
the cutting device 340 can include a single tubular member 110
having a cutting element 130 positioned adjacent to its distal
end.
[0036] In some embodiments, the cutting device 340 slides over the
handle 330. An inner lumen of the cutting device 340 provides a
close-sliding fit for the handle 330. As shown in FIG. 1, the
handle 330 extends beyond a proximal end of the cutting device 340,
thereby enabling an operator of the system 300 to grasp a proximal
portion of the handle 330 while advancing the cutting device 340
over the distal portion of the handle 330 and over the vessel
section to core out the vessel section and tissue adjoining the
vessel section. Only a distal portion of handle 330 is shown in
FIG. 1.
[0037] With the vessel harvesting system 300, a hemostatic control
method can be used to treat branch vessels severed by the cutting
device 340 as it is advanced over the vessel section. Various
hemostatic control methods are possible. For example, the
hemostatic control method can include the use of a biological
sealant or tissue adhesive, for example a platelet gel that is
prepared from the patient's blood and injected or otherwise
introduced along the track of the cutting device 340.
Alternatively, or in combination with a biological sealant, a
biocompatible or biodegradable tube can be enclosed within the
cutting device 340 to be delivered as the cutting device 340 is
advanced over the vessel or after the cutting device 340 has
completed coring out the vessel and adjoining tissue. A hemostatic
control tube can exert pressure on the cut branch vessels and can
be either removed or, in the case of a biodegradable tube, left in
place to dissolve or degrade over a period of a few days, for
example. Alternatively, the exterior of the tubular cutting device
340 can be coated with or deliver a procoagulant material such as
thrombin, collagen, a thrombotic polymer, or activating agent such
as kaolin or celite to promote clotting of the tissues as the
cutting device 340 is harvesting the vessel or after harvesting the
vessel. The tubular cutting device 340 can provide a hemostatic
control method as it exerts pressure on the cut branch vessels
while it remains within the patient's body. A fluid or gas, e.g.
saline or carbon dioxide, can be supplied at the tip of the tool to
deliver the fluid or gas into the tissue in the region where the
vessel is being harvested. The supplied fluid or gas will
accumulate and increase the pressure around the vessel being
harvested. The increased pressure can exceed the pressure in the
severed vessel branches and provide some hemostatic control by
collapsing the vessels and preventing blood from exiting the
severed end. A drain can be inserted at the end of the harvesting
procedure to deal with any bleeding that does occur.
[0038] An alternative embodiment of the vessel harvesting system
can include a rod 320, a handle 330 attached to the rod 320, and a
tubular cutting device 340. This system is similar to system 300
described above, but does not include a catheter 310. Rather, the
rod 320 is inserted directly into the vessel.
[0039] Yet another embodiment of the vessel harvesting system can
include a catheter 310, a rod 320, and a tubular cutting device
340. Again, this system is similar to system 300, with the
exception that no handle 330 is included in this system. Instead of
advancing over a handle 330, the cutting device 340 can be oriented
coaxial with the rod 320. The rod 320, when fully inserted into the
catheter 310 within the vessel to be harvested, can extend far
enough outside of the vessel to allow the cutting device 340 to be
aligned over the rod 320. The catheter 310 can be attached to the
rod 320 before advancing the cutting device 340 over the rod 320,
the catheter 310, and the vessel to core out the vessel section and
the tissue adjoining the vessel section.
[0040] Another embodiment of the system can include a rod or
guidewire 320 that extends beyond the distal end of the vessel and
beyond the proximal end of the handle 330. The portion of the rod
or guidewire 320 that extends beyond the vessel to be excised and
the cutting device 340 can be used to anchor the rod or guidewire
320 to a stable object, such as a surgical table or a bedrail. An
anchor device can be used to hold the rod or guidewire 320 and a
support device can be used to raise or lower the rod or guidewire
320 to a height necessary to be level with the vessel being
excised. The anchor and support devices can hold the rod or
guidewire 320 steady, straight, and level for the cutting device
340 to follow. In one embodiment, the vessel can be attached to the
catheter 310 and the rod and/or the guidewire 320. In one
embodiment, the catheter 310 and the rod or guidewire 320 can be
coupled to a tensioning device.
[0041] FIG. 2A is flow diagram of a vessel harvesting method
according to one embodiment of the invention. In this embodiment, a
first incision is made at a point corresponding to a proximal end
of the vessel section to be harvested (Block 405). A second
incision is made at a point corresponding to a distal end of the
vessel section (Block 410). A guidewire is then positioned within
the vessel section (Block 415). Alternatively, the guidewire can be
inserted into the vessel before the second incision is made.
Inserting the guidewire prior to making the second incision can aid
in determining the optimal location for the second incision. Once
the second incision has been made, the guidewire is positioned such
that it extends beyond and outside of the vessel section at both
the distal and proximal ends of the section.
[0042] A catheter is introduced into the vessel section over the
previously placed guidewire (Block 420). A proximal portion of the
vessel section is secured to the catheter (Block 425), for example
by suturing the vessel onto a barb positioned adjacent to the
proximal end of the catheter. Alternatively, the catheter can be
introduced into the vessel without a guidewire being previously
placed.
[0043] The guidewire (if present) is withdrawn (Block 430), and a
rod can be inserted into the catheter to stiffen the vessel section
(Block 435). Both the catheter and the rod can be attached to a
removable handle (Block 440). The handle can carry a tubular
cutting device, or the cutting device can be introduced over the
handle after the handle has been attached to the catheter and rod.
An inner lumen of the cutting device provides a close sliding fit
for the handle. The tubular cutting device is thus oriented coaxial
with the rod and with the vessel section to be harvested (Block
445).
[0044] The cutting device is then advanced over the vessel section
to core out the vessel section and tissue adjoining the vessel
section (Block 450). The cutting device can be advanced by either
pushing or pulling the device over the vessel section. Where the
cutting device comprises two tubular members, one positioned within
the other, the two tubular members can be advanced separately. For
example, inner tubular member can be advanced first to hold the
vessel and surrounding tissue, while outer tubular member is
advanced second to cut the tissue being held by the inner tubular
member. The process of incrementally advancing the inner tubular
member and then the outer tubular member is repeated until the
entire section has been excised. Advancing the inner tubular member
ahead of the outer tubular member can protect the walls of the
vessel from the cutting element positioned on the outer tubular
member. Advancing and rotating the inner and outer tubular members
separately can also protect the side branches of the vessel by
holding them in place to achieve a clean cut at a sufficient
length. The cutting device, for example, can be twisted first in
one direction and then in the other direction, or it can be rotated
over the vessel. The outer and inner tubular members can be twisted
in opposite directions to provide a scissoring action.
[0045] The cored out vessel section and adjoining tissue are
removed from the body of the patient (Block 455). Either before or
after removing the vessel section and adjoining tissue, a
hemostatic control method for branch vessels severed as a result of
coring out the vessel section can be introduced through either the
first or the second incision. The hemostatic control method can be,
for example, a biological sealant, e.g., platelet gel that can be
prepared from the patient's blood and injected or otherwise
introduced along the track of the cutting device. The hemostatic
control method can also be a thrombogenic substance such as
fibrinogen, fibrin and/or thrombin placed in the track left by the
cutting device. Alternatively, or in combination with a biological
sealant, a biocompatible or biodegradable tube can be enclosed
within the cutting device to be delivered as the cutting device is
advanced over the vessel or after the cutting device has completed
coring out the vessel and adjoining tissue. The tube exerts
pressure on the cut branch vessels and can be either removed or, in
the case of a biodegradable tube, left to dissolve or degrade over
a period of a few days, for example. The space left after the
removal of the vessel can also be filled with gauze to provide
internal pressure to limit bleeding and absorb blood. The gauze can
be removed periodically to check for absorbed blood. Limited blood
collected on the gauze indicates the wound bleeding has
diminished.
[0046] Hemostatic control methods are not required for embodiments
of the invention as the tubular cutting device itself can exert
pressure on the cut branch vessels while it remains within the
patient's body. A drain can be inserted at the end of the
harvesting procedure to deal with any bleeding that does occur. The
site of the vessel harvesting procedure, e.g., the leg of a
patient, can also be wrapped with a compression bandage to limit
bleeding.
[0047] In an alternative embodiment of the invention, a rod can be
inserted directly into the vessel. Thus, no guidewire and/or
catheter is used. In one embodiment, a proximal portion of the
vessel can be attached to the rod rather than to the catheter as
described above. The handle is then attached to the rod.
[0048] In another alternative embodiment, the catheter can be
inserted directly into the vessel. Thus, no guidewire or rod is
used. In one embodiment, the catheter includes one or more
inflatable structures, such as balloons. In yet another alternative
method in accordance with embodiments of the invention, no catheter
or rod is used; only a guidewire is used.
[0049] In yet another alternative embodiment, no handle is used.
Instead of being carried on the handle, the cutting device is
oriented coaxial with the rod. When fully inserted into the
catheter within the vessel to be harvested, the rod extends far
enough outside of the vessel to allow the cutting device to be
aligned with the rod. The catheter can be attached to the rod
before advancing the cutting device over the rod, catheter, and
vessel assembly.
[0050] FIG. 2B is a flow diagram illustrating a vessel harvesting
method according to another embodiment of the invention. A first
incision is made at a point corresponding to a proximal end of the
vessel section to be harvested (Block 405). A second incision is
made at a point corresponding to a distal end of the vessel section
(Block 410). A cannula is then inserted into the proximal end of
the vessel section, which is located near the knee. The proximal
end of the vessel is then secured to the cannula (Block 416), for
example by suturing the vessel onto a barb or raised portion
positioned adjacent to the distal end of the cannula. A balloon
catheter is then introduced through the cannula and positioned
within the vessel section (Block 421). Once positioned, the balloon
is inflated to stiffen the vessel section (Block 431). A
vessel-tensioning device or system is then attached to the cannula
to provide a vessel-tensioning force to the vessel section (Block
436).
[0051] A cutting device is oriented coaxially with the cannula, the
balloon and the vessel section to be harvested (Block 446). The
cutting device is then advanced over the vessel section to core out
the vessel section and tissue adjoining the vessel section (Block
450). The cutting device, for example, can be twisted first in one
direction and then in the other direction, or it can be rotated
over the vessel. The cored out vessel section and adjoining tissue
are removed from the body of the patient (Block 455). Either before
or after removing the vessel section and adjoining tissue, a
hemostatic control method for treating branch vessels severed as a
result of coring out the vessel section can be introduced through
either the first or the second incision. The hemostatic control
method can include, for example, a biological sealant, e.g.,
platelet gel that can be prepared from the patient's blood and
injected or otherwise introduced along the track of the cutting
device. The hemostatic control method can also be a thrombogenic
substance such as fibrinogen, fibrin and/or thrombin placed in the
track left by the cutting device. Alternatively, or in combination
with a biological sealant, a biocompatible or biodegradable tube
can be enclosed within the cutting device to be delivered as the
cutting device is advanced over the vessel or after the cutting
device has completed coring out the vessel and adjoining tissue.
The tube exerts pressure on the cut branch vessels and can be
either removed or, in the case of a biodegradable tube, left to
dissolve or degrade over a period of a few days, for example. The
space left after the removal of the vessel can also be filled with
gauze to provide internal pressure to limit bleeding and absorb
blood. The gauze can be removed periodically to check for absorbed
blood. Limited blood collected on the gauze indicates the wound
bleeding has diminished.
[0052] FIGS. 3A-3D illustrate a rollout intravascular sheath 800
according to one embodiment of the invention. The rollout
intravascular sheath 800 can be used to introduce a stabilizing or
support device, as discussed in more detail below, into a vessel
while protecting the endothelial layer of the vessel. The sheath
800 can provide support to the vessel during a vessel harvesting
procedure, e.g., a saphenous vein harvesting procedure. The sheath
800 can be a flexible tube, which is shown not fully extended in
FIGS. 3A-3D. A rigid or semi-rigid inner tube 802 is shown advanced
partially through the sliding sleeve 803. Prior to advancing the
tube 802 through the sliding sleeve 803, the sheath 800 is everted
around the edges of the sliding sleeve 803 and one end is fixedly
attached or bonded to the sliding sleeve 803, as shown in FIG. 3C.
The other end of the sheath 800 is fixedly attached or bonded to
one end of a wire 801, as shown in FIG. 8D. The tube 802 is
advanced over the wire 801, over a portion of the sheath 800 and
through the sliding sleeve 803. The tube 802 is advanced forward
into the sheath 800 and into the vessel section to be harvested.
Advancement of the tube 802 causes the flexible rollout sheath 800
to unroll as it enters the vein. The wire 801 is free to move with
the sheath 800 while the tube 802 is advanced forward thereby
allowing the sheath 800 to be unrolled. In one embodiment, there is
little to no relative motion, or sliding between sheath 800 and the
interior wall of the vessel. Unrolling the sheath 800 within the
vessel can minimize damage to the endothelial lining of the vessel
as compared to sliding a member against the endothelial lining of
the vessel as the member is advanced through the vessel.
[0053] The sheath 800 can be made of most any biocompatible
material, such as polyurethane or ePTFE. In one embodiment, as the
clinician advances the tube 802 in the vessel, the sheath 800
material is rolled out. While the tube 802 is advanced in the
vessel, the sliding sleeve 803 is held stationary, e.g., just
outside the vessel at a point adjacent the site of vessel
insertion. The tube 802 is advanced in the vessel to a length that
corresponds to the length of vessel that is intended to be
harvested. To remove the sheath 800 from the vessel, the wire 801
is pulled back, thereby retracting the sheath 800 and the tube 802
from the vessel and, thereby creating no relative motion between
the sheath 800 and the vessel.
[0054] FIG. 4A illustrates a one-piece intravascular balloon
catheter 900 according to one embodiment of the invention. The
intravascular balloon catheter 900 is plugged at its proximal end
902 and includes extended unexpanded balloon material. In one
embodiment, the balloon catheter 900 can be approximately 300-500
mm long with a 1.0-2.0 mm diameter when folded and 2.0-6.0 mm
diameter when inflated. The balloon catheter 900 can be constructed
of a suitable biocompatible material, such as nylon, urethane,
polyethylene, or PET. The elongated distal end or routing end 903
of balloon catheter 900 is used to navigate the balloon catheter
900 through the vessel and into place.
[0055] FIG. 4B illustrates a stylet 850 that can be placed within
the routing neck 903 of the balloon catheter 900 to prevent kinking
of the routing neck 903 during insertion within the vessel. In one
embodiment, the stylet 850 includes a flexible tip or cap 860 at
its distal end, a coiled wire 870, and a membrane 880. The flexible
tip 860 helps to minimize damage to the vessel wall when navigating
around curves. The flexible tip 860 can be tapered to allow easy
insertion into vessels of varying size. The proximal end 890 of the
stylet 850 can be positioned within the routing neck 903 of the
balloon catheter 900. The distal end 905 of the balloon catheter
900 is advanced over the coiled wire 870 and over the membrane 880,
thereby creating a pressure fit between the distal end 905 of the
routing neck 903 and the membrane 880 of the stylet 850. The
pressure fit couples the stylet 850 and the balloon catheter 900
together. The coupled stylet 850 and balloon catheter 900 together
can be navigated and routed through the vessel section to be
harvested. In one embodiment, as shown in FIG. 4C, the stylet 850
includes a flexible tip or cap 860 at its distal end and a coiled
wire 870. The proximal end 890 of the stylet 850 is positioned
within the routing neck 903 of the balloon catheter 900. In this
embodiment, the distal end 905 of the balloon catheter 900 is
positioned within a cavity 891, thus coupling or securing the
distal end 905 of the routing neck 903 and to the stylet 850, as
shown in FIG. 4D.
[0056] In one embodiment, a flexible sheath 871 can be placed over
the balloon catheter 900, as shown in FIGS. 4D-4E. The flexible
sheath 871 can be constructed of an elastic or resilient material
capable of allowing the balloon catheter 900 to be expanded or
inflated and also helping to deflate or collapse the balloon
catheter 900 into a low profile configuration similar to its
original configuration so that the balloon catheter 900 can be
easily removed from the vessel. FIG. 4E is a cross-sectional view
of a deflated balloon catheter 900 within the flexible sheath 871.
In one embodiment, the balloon catheter 900 is in a folded
configuration when it is in a deflated or collapsed configuration
within the flexible sheath 871.
[0057] FIG. 4F illustrates a flow delivered tethered balloon
catheter 900 according to one embodiment of the invention. This
embodiment utilizes a tether 906 coupled to the routing neck 903 to
introduce the balloon catheter 900 into a vessel section, e.g., a
saphenous vein, during a vessel harvesting procedure. The balloon
catheter 900 is sealed at its proximal end 902. In one embodiment,
the distal end 905 of the balloon catheter 900 is attached or
bonded to the proximal end of the tether 906. In one embodiment,
the routing neck 903 of the balloon catheter 900 can be
approximately 200 mm in length. In one embodiment, the tether 906
can be approximately 500 mm in length. A parachute 912 (in one
embodiment, approximately 2-5 mm in diameter) can be coupled or
attached to the proximal end of the tether 906. The parachute 912
can be a cup-shaped component, a lightweight ball, or another
suitable structure that is easily carried by fluid flow. The tether
906 can be a thin string, such as thread or suture material. The
tether 906 can also be constructed of a material with more
stiffness so that it could be pushed into the vein while injecting
fluid.
[0058] FIG. 6 illustrates one embodiment of an insertion device for
a flow delivered tethered balloon catheter 900, as shown in FIG.
4F. The tether 906 can be introduced into the vessel through a
vessel cannula 914 connected to a Y-connector 916 with a Touhy
Borst valve 918. The valve 918 can be tightened as much as possible
to prevent backflow of fluid, e.g., blood or saline, but still
allow the tether 906 to move. A port 920 of the Y-connector 916 is
used to inject fluid, e.g., saline. The cannula 914 is inserted
into the proximal end of a vessel section to be harvested, e.g., a
saphenous vein section, and sutured into position. For a saphenous
vein the proximal end of the section to be harvested is located
near the knee. The distal end of the vessel, near the groin region,
is opened to allow the parachute 912 to exit the vessel section to
be harvested. The tether 906 is injected into vessel at a location
near the knee using fluid, such as saline, to carry the parachute
912 from the knee to the groin incision. The balloon catheter 900
is then pulled into position within the vessel at a desired
location. After the balloon catheter 900 is inflated, the cutting
device is inserted at the knee incision to perform the harvest. The
fluid used to advance the parachute 912 can be saline, blood,
heparanized saline, or another suitable biocompatible fluid. In one
embodiment, one or more fluids can be injected through the port 920
to flush the vessel before, during and/or after insertion of the
balloon catheter 900. In one embodiment, the parachute 912 allows
the balloon catheter 900 to be pulled into the vessel by the tether
906, rather than being pushed into the vessel with a stylet, for
example.
[0059] In one embodiment, the vessel section to be harvested is
isolated at its proximal and distal ends. In one embodiment, a
saphenous vein section is isolated having a proximal end located
approximately near the knee, while the distal end is located at or
near the groin region. As shown in FIGS. 5A-51D, a distal tip 852
of a cannula 851, can be inserted into the proximal end of the
isolated vessel, e.g., a section of saphenous vein. The vessel is
then ligated to the cannula 851. A proximal end 853 of the cannula
851 can include a valve 854 to prevent back flow of fluid, such as
blood and/or saline, from the vessel out the cannula 851 end. In
one embodiment, the valve 854 is a bileaflet or duckbill valve, as
shown in FIGS. 5A-5D. In one embodiment, the proximal end 853 of
the cannula 851 can include a tension-coupling member 855, as shown
in FIGS. 5C-5D, for coupling a tensioning member to the cannula
851. In one embodiment, a twist lock mechanism can be used to
secure a tensioning device member 861, as shown in FIG. 5E, to the
cannula 851. The distal end 862 of tensioning device member 861 is
inserted, twisted and locked into place within tension coupling
member 855 located at the proximal end 853 of the cannula 851. In
one embodiment, a bayonet fastener mechanism can be used to couple
the tensioning device member 861 to the tension coupling member
855. For example, raised bumps 864 sized to fit within grooves 865
can be used to couple the tensioning device member 861 to the
tension coupling member 855. A tensioning device can be coupled to
tensioning device member 861 at its proximal end 863.
[0060] Once the vessel is cannulated, the balloon catheter 900 can
be routed through the vessel by routing the proximal neck 903 and
the stylet 850 through the cannula 851 and through the vessel
section to be harvested. Once the balloon catheter 900 is
positioned in its desired location within the vessel section to be
harvested, the stylet 850 may or may not be removed from the
routing neck 903. Following placement of the balloon catheter 900
within the vessel, the balloon catheter 900 can be inflated through
the distal end of the routing neck 903, which has exited out the
distal end of the vessel section. In one embodiment, the balloon
catheter 900 is inflated to a diameter of approximately 4 mm. The
balloon catheter 900 is semi-rigid when it is inflated, which
allows the vessel to still maintain most of its anatomical course.
When the balloon catheter 900 is inflated, it is rigid enough to
interface with the routing ridge 506, as discussed above. The
routing ridge 506, in combination with a cutting device having a
flexible distal end, allows the cutting device to accurately and
precisely navigate the vessel to ensure the harvesting of a viable
vessel section, e.g., acceptable for use as a graft in a CABG
procedure.
[0061] The balloon catheter 900 can be constructed of non-compliant
or semi-compliant materials, such as PET (polyethylene
terephthalate), nylon, Pebax and/or polyurethane, for example. Most
commonly, the balloon catheter 900 is folded and wrapped in a
collapsed configuration to create a low profile to assist in its
insertion into the vessel. The sheath 871 can be a section of
tubing made of an elastomer such as silicone and/or modified
silicone, such as C-flex, which is silicone modified styrenic
thermoplastic elastomer. The sheath 871 can be applied over the top
of the balloon catheter 900. The sheath 871 can expand with the
balloon catheter 900 when the balloon catheter 900 is inflated with
saline solution, and can return the balloon catheter 900 back to
its original low profile when the balloon catheter 900 is deflated.
Thus, the sheath 871 assists in an application where the balloon
catheter 900 is to be inserted into a vessel with a low profile,
inflated, and removed from the vessel with a low profile.
[0062] By returning the balloon to a low profile after it has been
inflated inside a vessel, the amount of damage to the inner vessel
walls is greatly reduced during removal of balloon catheter 900.
Non-compliant and semi-compliant balloons are often folded and
wrapped so that they have the lowest possible profile until they
reach their destination within the vessel. Then once the balloon
catheter reaches its desired area, it is inflated. Then in order to
remove the balloon catheter from the vessel, the balloon catheter
is deflated. However, the balloon catheter may not return to its
original low profile shape when deflated. This can be destructive
to the inner walls of the vessel as the balloon catheter can have
edges created by folds when the balloon catheter is deflated.
Therefore, the elasticity of the sheath 871 is used to bring the
deflated balloon catheter 900 back to its original profile.
[0063] FIGS. 7A-7F illustrate vessel support devices according to
various embodiments of the invention. The following discussion
discloses alternatives to using the balloon concepts discussed in
detail above for vessel support. Specifically, the following
discussion discloses ways to provide stabilization or support to a
vessel during a harvesting procedure by placing a support member
inside the vessel. These alternatives include inserting a rod or
dilator into a flexible sheath or coiled tube, using a wire braid
that increases in diameter when compressed, a tapered rod or
dilator, a rod or dilator with a flexible tip, a tube or dilator
having irrigation holes, and a rod or dilator with slippery,
lubricious coating, e.g., an Advawax coating or a hydrogel coating.
Other lubricious coatings, as discussed above, can be used. These
varied concepts all provide a support structure that is placed
within the vessel section that is to be harvested, thereby
providing the harvesting tool a structure to follow, while
preserving the endothelial lining of the vessel. Some of the
concepts provide for a small diameter during insertion and removal
and a larger diameter during the cutting procedure. Some
embodiments create a fluid barrier between the support member and
the vessel wall.
[0064] Inserting a rod or dilator into a flexible sheath or coiled
tube can be used to expand the flexible sheath or coiled tube. The
flexible sheath or coiled tube can be inserted into the vessel with
a smaller diameter, then expanded to a larger diameter with the rod
or dilator, thereby achieving the desired diameter and stiffness.
The rod or dilator can then be removed from the flexible sheath or
coiled tube when it is desirable to have a smaller diameter to
remove the flexible sheath or coiled tube from the vessel. The
flexible sheath can be an elastomeric tube, approximately the
length of the vessel section to be harvested. The flexible sheath
can be capable of expanding to the desired diameter when a rod or
dilator is inserted. Since the rod or dilator can be slid into the
flexible sheath or coiled tube, rod or dilator and sheath materials
that create minimal friction are desirable. The coiled tube can be
a piece of thin-walled, coiled polymer, such as Teflon, that had a
heat set in the coiled configuration. The coil can unwind as the
dilator is inserted, thereby expanding to the desired diameter.
[0065] FIG. 7A illustrates one embodiment of a dilator 930 that can
be placed within the vessel to be harvested. The dilator 930 has a
flexible tip 932 which is narrower than the diameter of dilator
930, e.g., approximately 5 mm. The tip 932 can extend roughly 1 cm
from the main body of the dilator 930 and can provide a guide for
insertion of the dilator 930 into a vessel section to be harvested.
The dilator 930 can be made of a Teflon material so it can slide
more easily though the vessel, thereby helping preserve the
endothelial lining of the vessel. In one embodiment, the dilator
930 can be inserted through a cannula 914 having diameter large
enough to allow the dilator 930 to pass through. One or more fluids
as discussed above can be injected through the port 920 to irrigate
the vessel before, during and/or after insertion of the dilator
930.
[0066] FIG. 7B illustrates one embodiment of the dilator 930 having
one or more holes 933. The holes 933 allow the user to inject one
or more fluids, e.g., saline, through the dilator 930 to create
pressure in the vessel thus expanding it outward and making the
insertion of the dilator 930 easier. The injection of fluid can
creates a fluid barrier between the dilator 930 and the vessel wall
to minimize endothelial damage.
[0067] The end of the vessel can be tied off to retain the added
fluid(s), such as saline. Fluid can be added to the vessel to
achieve an internal vessel pressure of roughly 50-200 mmHg during
insertion and removal of the dilator 930. In one embodiment,
fluid(s) containing one or more medical, biological and/or
pharmaceutical agents and/or drugs can be delivered to the vessel
before, during and/or after a vessel harvesting procedure. One or
more fluids can be delivered via one or more fluid delivery
devices, e.g., a syringe or a pressurized fluid reservoir. The
vessel can be secured by tying the vessel around features
protruding from the side of the dilator. In one embodiment, a
needle, for example, can be inserted into the vessel section to be
harvested. The needle is then used to fill the vessel section with
fluid(s) before, during and/or after insertion of the dilator 930.
In one embodiment, a small pressure relief hole can be created in
the vessel section to ensure the vessel is not damaged due to a
large internal fluid pressure during the harvesting procedure. In
one embodiment, a pressure gauge can be used to accurately monitor
the internal pressure of the fluid filled vessel section.
[0068] FIG. 7C illustrates a vessel support device 954 including a
braided cylindrical structure similar to a vascular stent. In one
embodiment, a flexible protective membrane 956 is placed over the
vessel support device 954 to protect the endothelial layer by
shielding the vessel wall from the wire braid during insertion and
removal of the vessel support device 954 during a vessel harvesting
procedure. After the vessel support device 954 is inserted into the
vessel, one end of the vessel support device 954 is then fixed to
the vessel. An insertion tool 958 is inserted within the vessel
support device 954 to cause the vessel support device 954 to expand
to the diameter of the vessel.
[0069] FIG. 8 illustrates a vein illumination device according to
one embodiment of the invention. As discussed, current vessel
harvesting is a tedious, labor-intensive process. Harvesting is
often accomplished with an electrosurgical tool to cut away tissues
around the vessel to be harvested so as to free the vessel, e.g.,
from the leg, the chest wall or other body structure. In some
harvesting procedures, the location of the vessel has to be
repeatedly assessed and verified by the surgeon to be sure to stay
clear of the vessel with the surgical toot to avoid damaging the
vessel. To prevent bleeding from the vessel or vessel attachment
points, side branches of the vessel can be occluded, for example,
via clips, sutures, or electrocautery. Therefore, some embodiments
of the invention include a method of illuminating the vessel from
the inside out to make the location of the vessel readily visible
in order to cut around it. Another embodiment involves a
catheter-like device within the vessel to act as a guide for an
external cutter to harvest the vessel away from the native tissue.
A further embodiment controls bleeding from the vessel side
branches by dispensing into the side branches a material that
occludes and plugs the side branch allowing the branch to be cut
without applying clips, sutures, or electrocautery. FIG. 8
illustrates illuminating a vessel 1100 with an intravenous catheter
device emitting light 1102, e.g., via fiber optics. This
illumination is designed to aid visualization of the vessel, e.g.,
the internal mammary artery (IMA), radial artery, saphenous vein or
similar vasculature during cut down to aid in the vessel harvesting
procedure.
[0070] FIG. 9 illustrates an intravenous catheter device 1104
placed within a vessel 1106 to serve as a centering guide for
advancing a vessel-cutting device 1108 along the exterior of vessel
1106.
[0071] FIG. 10 illustrates a hemostatic control device 1111
according to one embodiment of the invention. Hemostatic material
1110 is shown deployed from the hemostatic control device 1111
positioned within the vessel section to be harvested. In one
embodiment, vessel side branches 1112 of the vessel section to be
harvested can be occluded or plugged prior to the vessel harvesting
procedure. The hemostatic material 1110 can maintain hemostasis
without the time consuming process of ligating or cauterizing each
branch during a vessel harvesting procedure. The hemostatic
material 1110 can be made of UV curable glue or adhesive, a
platelet gel material, an expanding hydrogel material, and/or other
biocompatible hemostatic material.
[0072] FIG. 11 illustrates a vessel location and hemostasis device
according to one embodiment of the invention. In operation, a
hollow guide 1122 is inserted through the chest wall, for example.
A distal end of the hollow guide 1116 has a ring/oval magnet 1118
attached. The distal end is placed against vessel exterior 1120 at
a target anastomosis location. The hollow guide 1116 is then placed
into the vessel 1120, e.g., an IMA vessel. The hollow guide 1122
has a ring/oval magnet 1124 attached at its distal end. The
intravascular hollow guide 1116 is magnetically attracted to
extravascular hollow guide 1122 trapping the vessel wall between
them. Once the vessel wall between the two guides is penetrated,
the rings form a hemostatic seal and the hollow guides 1116 and
1122 now form a continuous channel to pass guidewires, catheters,
and/or hemostatic control devices through the vessel wall.
[0073] It will be appreciated by those skilled in the art that
while the invention has been described above in connection with
particular embodiments and examples, the invention is not
necessarily so limited, and that numerous other embodiments,
examples, uses, modifications and departures from the embodiments,
examples and uses are intended to be encompassed by the claims
attached hereto. The entire disclosure of each patent and
publication cited herein is incorporated by reference, as if each
such patent or publication were individually incorporated by
reference herein.
[0074] Various features and advantages of the invention are set
forth in the following claims.
* * * * *